• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K121631
Device Name SIMPLE T NASAL MASK
Original Applicant
RESPIRONICS, INC.
1001 murry ridge ln.
murrysville,  PA  15668
Original Contact michelle brinker
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/04/2012
Decision Date 10/05/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-